Healthy SubjectsPhase 1NCT01176201
14-C ADME (Absorption, Disposition, Metabolism and Excretion) Study in Man
A Phase 1 study testing SLV337 suspension and SLV337 capsule in people with Healthy Subjects, run by Abbott Products at 1 site in Netherlands.
Trial summary
This is an open-label study to determine the ADME (Absorption, Disposition, Metabolism and Excretion) of 14C labeled SLV337 after a single dose of an oral suspension. Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Subjects
- What is being tested?
- SLV337 suspension and SLV337 capsule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteNetherlands
- Study dates
- Jul 2010to Oct 2010
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- BMI 18 - 28 kg/m2
- SBP 90-140
- DBP 50-90
Who cannot join
- Seizures,
- Orthostatic hypotension
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Site Reference ID/Investigator# 61345
Zuidlaren, 9370 AE
About this study
Official title: An Open-Label Study to Determine ADME of 14C Labeled SLV337 After a Single Dose of an Oral Suspension
This is an open-label study to determine the ADME (Absorption, Disposition, Metabolism and Excretion) of 14C labeled SLV337 after a single dose of an oral suspension.
Read the detailed description
The Absorption, Disposition, Metabolism and Excretion of SLV337 will be investigated after a single dose of an oral suspension of 14C-SLV337.
- Conditions
- Healthy Subjects
- Being tested
- SLV337 suspension, SLV337 capsule
- Keywords
- SLV337, Diabetes, Relative bioavailability, ADME
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SLV337 suspensionDrug
400 mg experimental
SLV337 capsuleDrug
5 x 200 mg immediate release capsule
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | 400 mg suspension Receives: Drug: SLV337 suspension |
| B | Active comparator | 5 x 200 mg immediate release capsule Receives: Drug: SLV337 capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC0-t, AUC, Cmax, tmax, t1/2, λz, CL/F, Vz/F, MRT (mean residence time) for SLV337 (Part 1 and Part 2)
Measured: Part 1: 5 days Part 2: 8 days
AUC0-t, AUC, Cmax, tmax, t1/2, λz, CL/F, Vz/F, MRT (mean residence time) for SLV337 acyl-glucoronide (Part 2)
Measured: Part 2: 8 days
Excretion balance of total 14C-radioactivity (Part 2)
Measured: Part 2: 8 days
Total 14C-radioactivity (Part 2)
Measured: Part 2: 8 days
Metabolic profiling and identification of 14C-labeled parent compound and metabolites of SLV337 in plasma, urine and feces (Part 2)
Measured: Part 2: 8 days
Secondary outcomes (1)
Safety and tolerability assessments including adverse events, clinical laboratory tests, ECG and vital signs (Part 1 and Part 2)
Measured: Part 1: 19 days Part 2: 15 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2010 (estimated)
- Study startJul 2010
- Primary completionOct 2010
- Study completionOct 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy SubjectsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Products
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Anita Vanderlaan, Study director, Abbott Healthcare Products BV
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01176201
- Sponsor's protocol ID
- S337.1.005
- Other IDs
- 2010-020006-15
- Status last verified
- Aug 2011
- First submitted
- 20 Jul 2010
- Last updated
- 26 Aug 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label Study to Determine ADME of 14C Labeled SLV337 After a Single Dose of an Oral Suspension
- ClinicalTrials.gov ID
- NCT01176201
- Acronym / sponsor ID
- S337.1.005
- Conditions
- Healthy Subjects
- Keywords
- SLV337, Diabetes, Relative bioavailability, ADME
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Abbott ProductsIndustry (pharma, biotech, devices)
- Study start
- Jul 2010
- Primary completion
- Oct 2010 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 5 Aug 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is an open-label study to determine the ADME (Absorption, Disposition, Metabolism and Excretion) of 14C labeled SLV337 after a single dose of an oral suspension.
Detailed description
The Absorption, Disposition, Metabolism and Excretion of SLV337 will be investigated after a single dose of an oral suspension of 14C-SLV337.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: SLV337 suspension400 mg suspension |
| B | Active comparator | Drug: SLV337 capsule5 x 200 mg immediate release capsule |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- BMI 18 - 28 kg/m2
- SBP 90-140
- DBP 50-90
Key exclusion criteria (2 listed)
- Seizures,
- Orthostatic hypotension
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SLV337 suspension400 mg experimental | Drug | A |
| SLV337 capsule5 x 200 mg immediate release capsule | Drug | B |
Primary outcome
AUC0-t, AUC, Cmax, tmax, t1/2, λz, CL/F, Vz/F, MRT (mean residence time) for SLV337 (Part 1 and Part 2)
Time frame: Part 1: 5 days Part 2: 8 days
AUC0-t, AUC, Cmax, tmax, t1/2, λz, CL/F, Vz/F, MRT (mean residence time) for SLV337 acyl-glucoronide (Part 2)
Time frame: Part 2: 8 days
Excretion balance of total 14C-radioactivity (Part 2)
Time frame: Part 2: 8 days
Total 14C-radioactivity (Part 2)
Time frame: Part 2: 8 days
Metabolic profiling and identification of 14C-labeled parent compound and metabolites of SLV337 in plasma, urine and feces (Part 2)
Time frame: Part 2: 8 days
1 secondary outcome
Safety and tolerability assessments including adverse events, clinical laboratory tests, ECG and vital signs (Part 1 and Part 2)
Time frame: Part 1: 19 days Part 2: 15 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anita Vanderlaan study director
Abbott Healthcare Products BV
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing SLV337 suspension and SLV337 capsule in people with Healthy Subjects, run by Abbott Products at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Aug 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AUC0-t, AUC, Cmax, tmax, t1/2, λz, CL/F, Vz/F, MRT (mean residence time) for SLV337 (Part 1 and Part 2) (time frame: Part 1: 5 days Part 2: 8 days). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2011.